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Effect of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in People With Persistent Symptoms During the Subacute Period After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02226848
Recruitment Status : Withdrawn
First Posted : August 27, 2014
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

- Traumatic brain injury (TBI) injures blood vessels in the brain. Endothelial progenitor cells (EPCs) help the body form new blood vessels. The drug erythropoietin (EPO) helps the body make more blood cells and might help make blood vessels. Researchers want to see if EPO helps people with TBI.

Objective:

- To see whether erythropoietin increases the number of endothelial progenitor cells circulating in the blood and changes reactivity of brain vessels.

Eligibility:

- Adults age 18 70 who had a TBI 3 7 days ago and still have symptoms.

Design:

  • Participants will be screened with medical history and blood tests. Vital signs will be taken.
  • Visit 1:
  • Medical history, physical exam, and blood sample.
  • Neuropsychological tests of memory, attention, and thinking. These include written and spoken questions, tests on paper or computer, and simple actions.
  • Magnetic resonance imaging (MRI) scan with carbon dioxide. Participants will lie on a table that slides in and out of a metal cylinder. For part of the scan, participants will wear a breathing mask like a snorkel and wear a nose clip.
  • Study drug or placebo injection under the skin of the arm, leg, or buttock.
  • Visits 2, 3, and 4 will be 1 week apart.
  • Blood sample.
  • Review of TBI symptoms and any drug side effects.
  • Study drug or placebo injection under the skin.
  • Visit 5 will be 1 week after visit 4. Visit 6 will be 6 months after participants start the study.
  • Blood sample.
  • Review of TBI symptoms and any drug side effects.
  • Neuropsychological tests.
  • MRI with carbon dioxide.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Erythropoeitin Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Effect of Administration of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Patients With Persistent Symptoms During the Subacute Period After TBI
Study Start Date : August 15, 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effect of 4 weeks of EPO administration on numbers of circulating EPCs in patients with persistent symptons during the subacute period after TBI. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Safety of 4 weeks of EPO administration to TBI participants [ Time Frame: 4 weeks ]
  2. Effect of 4 weeks of EPO administration on MRI biomarkers of TBI recovery [ Time Frame: 4 weeks ]
  3. Effect of 4 weeks of EPO administration on biomarkers [ Time Frame: 4 weeks ]
  4. Relationship between EPC levels at baseline after 4 weeks and neuropsychological performance following TBI. [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age 18 - 70 years, inclusive
    2. History of having sustained a TBI greater than or equal to 3 days and less than or equal to 7 days prior to enrollment. This evidence will be any one of the following:

      1. GCS 3 - 12 on first presentation to medical attention
      2. Post-traumatic amnesia > 24 hours
      3. TBI-related abnormality on neuroimaging (either CT or MRI)
    3. Persistent post-concussive symptoms, according to the DSM-IV Research Criteria for Post- Concussional Disorder.

      1. Three of more of the following symptoms, which started shortly after the trauma and persist for at least up to the time of enrollment:

        • Fatigueability
        • Disordered sleep
        • Headache
        • Vertigo or dizziness
        • Irritability or aggression
        • Anxiety, depression, or affective instability
        • Changes in personality (e.g., social or sexual inappropriateness)
        • Apathy or lack of spontaneity
      2. Symptoms had their onset after trauma, or there is a significant worsening or preexisting symptoms after trauma.
    4. Ability to read, write, and speak English
    5. Ability to give consent by the participant himself
    6. Willingness of women of childbearing potential to use effective contraception during this study and until 2 weeks after they have completed the study drug (EPO or placebo).

Effective methods of contraception for this study include:

  • hormonal contraception (birth control pills, injected hormones or vaginal ring),
  • intrauterine device,
  • barrier methods (condom or diaphragm) combined with spermicide,
  • surgical sterilization (hysterectomy, tubal ligation), or vasectomy in a partner.

EXCLUSION CRITERIA:

  1. Contraindication to EPO therapy:

    1. Known allergy to EPO, hypersensitivity to mammalian cell-derived products, or hypersensitivity to albumin
    2. Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a platelet count > 400,000/mm3 or serum hemoglobin < 10 g/dL in either a male or female patient
    3. liver or kidney disease; the former will be operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase (AP) > 250 U/L, aspartate aminotransferase (SGOT, AST) > 150 U/L, alanine aminotransferase (SGPT, ALT) >150 U/L, or Moderately decreased GFR 30-59 ml/min/1.73m2
    4. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female of childbearing potential
  2. Use of EPO one month prior to the randomization
  3. Suspicion of a coagulation disorder associated with bleeding (PTT>45 or INR>1.7, spontaneously out of normal range)
  4. Pre-existing and active major disabling psychiatric disorder (e.g., schizophrenia or bipolar disorder), or other neurological disease (epilepsy, multiple sclerosis, developmental disorder) not related to TBI
  5. History of heart disease or heart attack, congestive heart failure, stroke, venous thromboembolism.
  6. History of disorders that predispose to coagulation (e.g. polycythemia vera, essential thrombocytosis, or thrombotic thrombocytopenic purpura).
  7. Uncontrolled hypertension, defined as above 140/90 mm Hg in three measurements in two separate visits despite antihypertensive therapy. Antihypertensive therapy is allowed, including agents such as thiazide diuretics, ACE inhibitors, beta-blockers, calcium channel blockers, alpha-blockers, or a centrally acting alpha agonists.
  8. Known malignant conditions, e.g., melanoma, breast, brain, lung tumor or prostate cancer
  9. Terminal medical diagnosis consistent with survival < 1 year
  10. Planned surgical procedure during duration of the study (if emergency surgery needed, EPO administration will be stopped, but the patient will remain in the study according to the intention to treat principles).
  11. Current use of Coumadin or other blood thinners (e.g. Pradaxa, Heparin, Lovenox)

    ASA, Plavix or Aggrenox are not a contraindication

  12. Any history of previous deep venous thrombosis (DVT), pulmonary embolization (PE), or other thromboembolic event
  13. Current participation in other interventional clinical trial
  14. Current use of iron supplements
  15. Evidence of penetrating brain injury
  16. Contraindication to MRI scanning
  17. No adherence to use of effective method of contraception for females of childbearing potential for time from enrollment to the study until 2 weeks after completion of the study drug (EPO or placebo)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226848


Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Eric M Wassermann, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02226848     History of Changes
Other Study ID Numbers: 140174
14-N-0174
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: May 31, 2017
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Endothelial Progenitor Cells
Angiogenesis
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Epoetin Alfa
Hematinics